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The Endo GIA™ Universal Staplers with Duet TRS™ reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. The Duet TRS™ Reloads with Tri-Staple™ Technology have applications in abdominal, gynecologic and pediatric surgery for resection and creation of anastomoses. They may be used for resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

The Duet TRS™ Reloads when used with Endo GIA™ Staplers place two, triple-staggered rows of titanium staples along with two layers of absorbable tissue reinforcement material (one layer on cartridge side and one laver on anvil side) and simultaneously divides the tissue and reinforcement material between the two, triple-staggered staple rows. The Duet TRS™ Reloads with Tri-Staple™ Technology when used with Endo GIA™ Staplers places two, triple-staggered rows of titanium staples along with two layers of absorbable tissue reinforcement material (one layer on cartridge side and one layer on anvil side) and simultaneously divides the tissue and reinforcement material between the two, triple-staggered staple rows. The staple line reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material supplied on each Reload is undyed (natural) and secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture. The Endo GIA™ Universal and Ultra Universal Staplers (K111825) with associated staple cartridge reloads are articulating, disposable surgical staplers that simultaneously transect and staple various types of internal tissues. Each can be used in both endoscopic and open surgical procedures, is available in multiple sizes, is for endoscopic procedures and can be introduced and used through appropriately sized trocar endoscopic access cannulae.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for a medical device study.

The document is a 510(k) summary for Duet TRS™ Reloads, which are surgical staplers. It primarily focuses on:

• Identification of the device and submitter.
• Description of the device and its intended use.
• Comparison to predicate devices.
• Confirmation of materials used.
• A statement that performance evaluations were NOT required to support a labeling modification, indicating that no new performance data was generated for this specific submission.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets them, as the necessary information is absent from the provided text.

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